WO2022231972A1

WO2022231972A1 - System, method and apparatus for anchoring and retaining a tube on a face of a user

Info

Publication number: WO2022231972A1
Application number: PCT/US2022/025956
Authority: WO
Inventors: Matthew Lawson; Henry MEZA
Original assignee: Nutri-Tube, Llc
Priority date: 2021-04-26
Filing date: 2022-04-22
Publication date: 2022-11-03

Abstract

An assembly for adhesive anchoring of a tube includes an anchoring device having a planar body having a top, a bottom opposite the top, an outer surface configured to face away from a face of a user, an underside opposite the outer surface configured to face toward the face of the user, left side portions and right side portions opposite the left side portions. An axis extends between the left and right side portions. A recess is formed between each of the left and right side portions, such that the recesses extend toward each other along the axis but do not engage each other. The side portions are contoured to be complementary in shape to an exterior of a nostril. The anchoring device has a central portion extending along the axis between the recesses that extends along and with the tube. An adhesive and release liner also are included.

Description

INTERNATIONAL APPLICATION

SYSTEM, METHOD AND APPARATUS FOR ANCHORING AND RETAINING A TUBE ON A FACE OF A

USER

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and the benefit of U.S. Patent Application Serial No. 63/179,670, filed April 26, 2021, titled "System, Method and Apparatus for Anchoring and Retaining a Tube on a Face of a User". The entire disclosures of the above-referenced applications are hereby incorporated by reference.

BACKGROUND

[0002] This disclosure generally relates to tube retention and, in particular, to a system, method and apparatus for anchoring and retaining a tube on a face of user adjacent to a nose of the user.

SUMMARY

[0003] Embodiments of an assembly for adhesive anchoring of a tube includes an anchoring device having a planar body having a top, a bottom opposite the top, an outer surface configured to face away from a face of a user, an underside opposite the outer surface configured to face toward the face of the user, left side portions and right side portions opposite the left side portions. An axis extends between the left and right side portions. A recess is formed between each of the left and right side portions, such that the recesses extend toward each other along the axis but do not engage each other. At least one of the left and right side portions have a concave shape such that at least one of the left and right side portions is contoured to be complementary in shape to an exterior of a nostril of the user of the anchoring device. The anchoring device has a central portion extending along the axis between the recesses that extends along and with the tube. An adhesive is on the underside of the anchoring device and can be attached directly to a face of the user without an intervening structure to enable the anchoring device to releasably secure the tube to the face of the user. A release liner is releasably bonded to the adhesive on the anchoring device.

BRIEF DESCRIPTION OF THE DRAWINGS

[0004] For a detailed description of example embodiments, reference will now be made to the accompanying drawings in which:

[0005] FIG. 1 is a plan view of an embodiment of an anchoring device.

[0006] FIGS. 2 and S are plan and side views, respectively, of the device of FIG. 1 on a release liner.

[0007] FIGS. 4A, 4B, 5A, 5B, 6A and 6B are plan views of alternate embodiments of anchoring devices.

[0008] FIG. 7 is an image of the anchoring device of FIG. 1 in operation.

DETAILED DESCRIPTION

[0009] The following discussion is directed to various embodiments. Although one or more of these embodiments may be preferred, the embodiments disclosed should not be interpreted, or otherwise used, as limiting the scope of the disclosure, including the claims. In addition, one skilled in the art will understand that the following description has broad application, and the discussion of any embodiment is meant only to be exemplary of that embodiment, and not intended to intimate that the scope of the disclosure, including the claims, is limited to that embodiment.

[0010] FIGS. 1-7 disclose embodiments of a system, method and apparatus for anchoring and retaining a tube on a face of user adjacent to a nose of the user. One example includes an embodiment of an assembly 100 (FIG. 2) for adhesive anchoring of a tube 199 (FIG. 7), such as for percutaneous use. Versions of the assembly 100 can include an anchoring device 102 comprising a planar body having a top 104 and a bottom 106 opposite the top 104. An outer surface 106 is configured to face away from a face of a user. An underside (not numbered) opposite the outer surface 106 is configured to face toward the face of the user.

[0011] Embodiments of the anchoring device 102 also have left side portions 108, 110 and right side portions 112, 114 opposite the left side portions 108, 110. An axis 120 extends between the left and right side portions 108-114. A recess 122 is formed between each of the left side portions 108, 110. Another recess 124 is formed between each of the right side portions 112, 114, such that the recesses 122, 124 extend toward each other along the axis 120 but do not engage each other. Each of the left and right side portions 108-114 comprise a concave shape such that at least one of the left and right side portions 108-114 is contoured to be complementary in shape to an exterior of a nostril of the user (FIG. 7) of the anchoring device 102. The anchoring device 102 also can include a central portion 130 extending along the axis 120 between the recesses 122, 124 that is configured to extend along and with the tube 199.

[0012] In some versions, an adhesive 140 is located on the underside of the anchoring device 102. The adhesive can be configured to be attached directly to a face of the user to enable the anchoring device 102 to releasably secure the tube 199 to the face of the user.

[0013] In addition, a release liner 150 can be releasably bonded to the adhesive 140 on the anchoring device 102. Embodiments of the release liner 150 can have a release liner major surface area that is greater than an anchoring device major surface area of the anchoring device 102. For example, the release liner major surface area can be 1.5 to 2.0 times greater than the anchoring device major surface area.

[0014] In some embodiments, the tube 199 (FIG. 7) is configured to remain linear and unobstructed from an ingress of the tube 199 beneath the central portion 130 of the anchoring device 102 to an egress of the tube away from the central portion 130 of the anchoring device 102. The tube 199 can bond to the adhesive 140 located on the underside of the central portion 130.

[0015] Versions of the anchoring device 102 can have an overall axial length 152, and the recesses 122, 124 have a combined axial length 154. A ratio of the overall axial length 152 to the combined axial length 154 can be at least about 1:5 to about 2.0. Embodiments of the anchoring device 102 can have an overall width 153 (in radial direction, relative to axis 120) that is less than the overall axial length 152. In some versions, a ratio of overall axial length 152 to overall width 153 can be in a range of 1.1 to 1.5.

[0016] In one example, the anchoring device 102 is symmetrical about the axis 120. In another example, the anchoring device 120 is asymmetrical about the axis 120.

[0017] Embodiments of the left side portions 108, 110 have a greater radial dimension 111, relative to the axis 120, than the radial dimension 115 of the right side portions 112, 114.

[0018] In some versions, the anchoring device 120 is reversible. For example, the left side portions 108, 110 can be placed immediately adjacent, receive and be complementary in shape to a left nostril of the user, as shown in FIG. 7. Alternatively, the anchoring device 102 can be inverted (see dashed lines in FIG. 7) such that the left side portions 108, 110 can be placed immediately adjacent, receive and be complementary in shape to a right nostril of the user. [0019] Embodiments of the left side portions 108, 110 have the concave shapes to enable the anchoring device 102 to receive and be positioned immediately adjacent to the nostril of the user while allowing substantially all of the adhesive 140 (and the anchoring device 102) to conform to and remain in direct contact with the face of the user, other than the central portion 130 of the anchoring device 102. In one version, the adhesive is not configured to be secured to a separate appliance that is located on the face of the user, directly between the face of the user and the anchoring device 102.

[0020] As shown in FIG. 3, each of anchoring device 102, adhesive 140 and release liner 150 have a respective thickness. The release liner thickness can be greater than the adhesive thickness, which can be greater than the anchoring device thickness. In one example, the adhesive can comprise a thickness of 34 mils (0.9 mm). In another example, the anchoring device can have a thickness of 32 mils (0.8 mm). In one version the release liner 150 can have a thickness of 40 mils (1.0 mm). In some versions, the anchoring device 102 comprises a foam material, and the release liner 150 comprises a disposable paper or liner material. As an example, the assembly 100 may comprise a polyethylene foam with a medical grade, pressure-sensitive acrylic adhesive, and a clay and silicone coated, one-side backing, such as DM-5001 by DermaMed Coatings Company, LLC, of Tallmadge, Ohio.

[0021] Alternate embodiments are depicted in FIGS. 4-6. For example, the anchoring device 202 can comprise a butterfly shape and design (FIGS. 4A-4B) that is releasably mounted to a release liner 250. In FIG. 5A-5B, the anchoring device 302 can comprise a soccer ball shape and design that is releasably mounted to a release liner 350. In another example, the anchoring device 402 can comprise a turtle shape and design (FIGS. 6A-6B) that is releasably mounted to a release liner 450.

[0022] These embodiments can secure medical tubing to the skin of the user. The structure is designed to form an ergonomic flow with the face of the user. This allows the device to be non obstructive and low-profile (without a cumbersome, intervening structural base), which overcomes medical difficulties that are common with conventional medical tapes and devices. In addition, these embodiments provide care-givers with accuracy in placing and securing the medical device to reduce time consumption.

[0023] The products and packaging are sanitary. The sterilized product allows use in hospitals and other medical facilities. The shape and low profile provide comfortable wear for the user, when the user lays their face over the device. In addition, the device is sized to allow adequate space for tubes of different sizes (and yet be restrained) without issue. The design reduces the possibility of the user accidently removing the tube when in use.

[0024] The device can be removed from a sanitized package. A backing strip can be removed to expose the adhesive backing. The adhesive backing can be applied directly to the skin of the user at an appropriate location. A caregiver can gently insert a medical tube through the device to confirm that full connection is made with the bottom adhesive. Alternatively, the tube can be applied to the user, or the one side of product can be applied to the user, the tube can be applied to the user, and then the other side of the product can be applied to the user, such that the product and tube are applied in series or together at the same time.

[0025] Embodiments can be removed from the skin once a week, or as often as desired. The adhesive can comprise a highly bondable and gentle adhesive for sensitive skin. It is particularly well suited for newborn children, as well as aged adults. [0026] Other embodiments include a system and method of installing and using a system with an anchoring device as described herein. Still other examples follow.

[0027] 1. An assembly for adhesive anchoring of a tube, the assembly comprising:

[0028] an anchoring device comprising a planar body having a top, a bottom opposite the top, an outer surface configured to face away from a face of a user, an underside opposite the outer surface configured to face toward the face of the user, left side portions, right side portions opposite the left side portions, an axis extending between the left and right side portions, a recess formed between each of the left and right side portions, such that the recesses extend toward each other along the axis but do not engage each other, at least one of the left and right side portions comprise a concave shape such that at least one of the left and right side portions is contoured to be complementary in shape to an exterior of a nostril of the user of the anchoring device, and the anchoring device comprises a central portion extending along the axis between the recesses that is configured to extend along and with the tube;

[0029] an adhesive on the underside of the anchoring device, the adhesive being configured to be attached directly to a face of the user without an intervening structure to enable the anchoring device to releasably secure the tube to the face of the user; and [0030] a release liner releasably bonded to the adhesive on the anchoring device.

[0031] 2. The assembly wherein the tube is configured to remain linear and unobstructed from an ingress of the tube, beneath the central portion of the anchoring device and to an egress of the tube away from the central portion of the anchoring device.

[0032] 3. The assembly wherein the anchoring device has an overall axial length, the recesses have a combined axial length, and a ratio of the overall axial length to the combined axial length is in a range of 1:5 to 2.0.

[0033] 4. The assembly wherein the anchoring device is symmetrical about the axis.

[0034] 5. The assembly wherein the anchoring device is asymmetrical about the axis.

[0035] 6. The assembly wherein the left side portions have a greater radial dimension, relative to the axis, than the right side portions.

[0036] 7. The assembly wherein the anchoring device is reversible, such that the left side portions can be placed immediately adjacent and complementary in shape to a left nostril of the user, or the anchoring device can be inverted such that the left side portions can be placed immediately adjacent and complementary in shape to a right nostril of the user.

[0037] 8. The assembly wherein the release liner has a release liner major surface area that is greater than an anchoring device major surface area of the anchoring device.

[0038] 9. The assembly wherein the release liner major surface area is 1.5 to 2.0 times greater than the anchoring device major surface area.

[0039] 10. The assembly wherein the concave shape enables the anchoring device to receive and be positioned immediately adjacent to the nostril of the user while allowing substantially all of the adhesive to conform to and remain in direct contact with the face of the user, other than the central portion of the anchoring device.

[0040] 11. The assembly wherein the adhesive is not configured to be secured to an appliance located directly between the face of the user and the anchoring device.

[0041] 12. The assembly wherein each of anchoring device, adhesive and release liner have a respective thickness, the release liner thickness is greater than the adhesive thickness which is greater than the anchoring device thickness.

[0042] 13. The assembly wherein the anchoring device comprises a foam, and the release liner comprises a disposable paper.

[0043] 14. The assembly wherein the anchoring device comprises an overall width that is less than an overall axial length thereof, and a ratio of the overall axial length to the overall width is in a range of 1.1 to 1.5.

NOTATION AND NOMENCLATURE

[0044] Various terms are used to refer to particular system components. Different companies may refer to a component by different names - this document does not intend to distinguish between components that differ in name but not function. In the following discussion and in the claims, the terms "including" and "comprising" are used in an open-ended fashion, and thus should be interpreted to mean "including, but not limited to... ." Also, the term "couple" or "couples" is intended to mean either an indirect or direct connection. Thus, if a first device couples to a second device, that connection may be through a direct connection or through an indirect connection via other devices and connections.

[0045] The terminology used herein is for the purpose of describing particular example embodiments only, and is not intended to be limiting. As used herein, the singular forms "a," "an," and "the" may be intended to include the plural forms as well, unless the context clearly indicates otherwise. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order discussed or illustrated, unless specifically identified as an order of performance. It is also to be understood that additional or alternative steps may be employed.

[0046] The terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections; however, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as "first," "second," and other numerical terms, when used herein, do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments. The phrase "at least one of," when used with a list of items, means that different combinations of one or more of the listed items may be used, and only one item in the list may be needed. For example, "at least one of: A, B, and C" includes any of the following combinations: A, B, C, A and B, A and C, B and C, and A and B and C. In another example, the phrase "one or more" when used with a list of items means there may be one item or any suitable number of items exceeding one.

[0047] Spatially relative terms, such as "inner," "outer," "beneath," "below," "lower," "above," "upper," "top," "bottom," and the like, may be used herein. These spatially relative terms can be used for ease of description to describe one element's or feature's relationship to another element(s) or feature(s) as illustrated in the figures. The spatially relative terms may also be intended to encompass different orientations of the device in use, or operation, in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented

"above" the other elements or features. Thus, the example term "below" can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptions used herein interpreted accordingly.

[0048] This disclosure is meant to be illustrative of the principles and various embodiments. Benefits, other advantages, and solutions to problems have been described above with regard to specific embodiments. However, the benefits, advantages, solutions to problems, and any feature(s) that can cause any benefit, advantage, or solution to occur or become more pronounced are not to be construed as a critical, required, sacrosanct or an essential feature of any or all the claims. Numerous variations and modifications will become apparent to those skilled in the art once the above disclosure is fully appreciated. It is intended that the following claims be interpreted to embrace all such variations and modifications.

[0049] The various aspects, implementations or features of the described embodiments can be used separately or in any combination. The embodiments disclosed herein are modular in nature and can be used in conjunction with or coupled to other embodiments.

[0050] Consistent with the above disclosure, the examples of assemblies enumerated in the following clauses are specifically contemplated and are intended as a non-limiting set of examples.

Claims

CLAIMS What is claimed is:

1. An assembly for adhesive anchoring of a tube, the assembly comprising: an anchoring device comprising a planar body having a top, a bottom opposite the top, an outer surface configured to face away from a face of a user, an underside opposite the outer surface configured to face toward the face of the user, left side portions, right side portions opposite the left side portions, an axis extending between the left and right side portions, a recess formed between each of the left and right side portions, such that the recesses extend toward each other along the axis but do not engage each other, at least one of the left and right side portions comprise a concave shape such that at least one of the left and right side portions is contoured to be complementary in shape to an exterior of a nostril of the user of the anchoring device, and the anchoring device comprises a central portion extending along the axis between the recesses that is configured to extend along and with the tube; an adhesive on the underside of the anchoring device, the adhesive being configured to be attached directly to a face of the user without an intervening structure to enable the anchoring device to releasably secure the tube to the face of the user; and a release liner releasably bonded to the adhesive on the anchoring device.

2. The assembly of claim 1, wherein the tube is configured to remain linear and unobstructed from an ingress of the tube, beneath the central portion of the anchoring device and to an egress of the tube away from the central portion of the anchoring device.

3. The assembly of claim 1, wherein the anchoring device has an overall axial length, the recesses have a combined axial length, and a ratio of the overall axial length to the combined axial length is in a range of 1:5 to 2.0.

4. The assembly of claim 1, wherein the anchoring device is symmetrical about the axis.

5. The assembly of claim 1, wherein the anchoring device is asymmetrical about the axis.

6. The assembly of claim 1, wherein the left side portions have a greater radial dimension, relative to the axis, than the right side portions.

7. The assembly of claim 1, wherein the anchoring device is reversible, such that the left side portions can be placed immediately adjacent and complementary in shape to a left nostril of the user, or the anchoring device can be inverted such that the left side portions can be placed immediately adjacent and complementary in shape to a right nostril of the user.

8. The assembly of claim 1, wherein the release liner has a release liner major surface area that is greater than an anchoring device major surface area of the anchoring device.

9. The assembly of claim 8, wherein the release liner major surface area is 1.5 to 2.0 times greater than the anchoring device major surface area.

10. The assembly of claim 1, wherein the concave shape enables the anchoring device to receive and be positioned immediately adjacent to the nostril of the user while allowing substantially all of the adhesive to conform to and remain in direct contact with the face of the user, other than the central portion of the anchoring device.

11. The assembly of claim 1, wherein the adhesive is not configured to be secured to an appliance located directly between the face of the user and the anchoring device.

12. The assembly of claim 1, wherein each of anchoring device, adhesive and release liner have a respective thickness, the release liner thickness is greater than the adhesive thickness which is greater than the anchoring device thickness.

13. The assembly of claim 1, wherein the anchoring device comprises a foam, and the release liner comprises a disposable paper.

14. The assembly of claim 1, wherein the anchoring device comprises an overall width that is less than an overall axial length thereof, and a ratio of the overall axial length to the overall width is in a range of 1.1 to 1.5.